FDA Chief Hamburg Resigns

After six years heading FDA, Margaret Hamburg, MD, will resign her post as commissioner in March.

Nancy Crotti

Stephen Ostroff, the agency's chief scientist and a former official at the Centers for Disease Control and Prevention, will be interim commissioner until President Obama names a successor.

In the past year alone, Hamburg presided over FDA efforts at food safety, tobacco control opioid abuse, antibiotic resistance, pharmacy compounding, and nutrition. She has also worked to fast-track approval of novel drugs and of medical devices.

"As you can imagine, the decision was not easy," Hamburg said in a statement reported in the Wall Street Journal. "While there is still work ahead (and there will always be), I know that I am leaving the agency well-positioned to fulfill its responsibilities to the American public with great success."

In that statement, she also touched on the agency's accomplishments related to medical devices under her tenure:

Robert Califf, MD, whom Hamburg appointed January 26 as commissioner for medical products and tobacco, is widely expected to succeed her, according to news reports. Califf is a prominent cardiologist from Duke University.

During her tenure, Hamburg has taken heat over prescription drug overdoses, and the 2012 outbreak of fungal meningitis linked to an unregulated compounding pharmacy.

She also weathered a challenge by then-Health and Human Services commissioner Kathleen Sibelius over sales to young women of Plan B, an over-the-counter, morning-after contraceptive. The Obama administration later approved over-the-counter sales of Plan B to women of all ages.

The day before announcing her pending resignation, Hamburg wrote a blog post about FDA's achievements during the past year.

The agency approved 51 novel drugs and biologics, the most in almost 20 years, she wrote. It also cut down the average length of time from the submission of an application to run a medical device trial, to a decision on the application, by 75% in the past three years.

"Whether our achievements involved medical product safety and innovation, food safety and nutrition, tobacco control, or other areas of our important work, all were accomplished thanks in large part to our ability to respond to evolving needs and opportunities including the embrace of new approvals, technologies and cutting-edge science," she added.

Separately, Hamburg called her tenure at FDA a privilege, adding that she made the decision to resign with mixed emotions, CNN reported.

What next? In his new job, Califf will have some good training for taking over as commissioner, should Obama nominate him and Congress approve him. He will lead the agency's Center for Devices and Radiological Health, Center for Drug Evaluation and Research, and Center Biologics Evaluation and Research as well. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.

A new commissioner will have big shoes to fill. A Harvard Medical School graduate, conducted research on neuroscience at Rockefeller University, studied neuropharmacology at the National Institute of Mental Health, and later focused on AIDS research as assistant director of the National Institute of Allergy and Infectious Diseases.

From 2005 to 2009, Hamburg was the senior scientist at the Nuclear Threat Initiative, a public safety foundation also concerned with chemical and biological weapons.

FDA commissioner was not her first federal government stint. In 1997, Hamburg was named assistant secretary for policy and evaluation in the U.S. Department of Health and Human Services. In 1994, she was elected to the membership in the Institute of Medicine, one of the youngest persons to be so honored.

From 1991 to 1997, Hamburg served as commissioner of the New York City Department of Health and Mental Hygiene, improving services for women and children, promoting needle-exchange programs to reduce the spread of HIV, and initiating the nation's first public health bioterrorism defense program. She also curbed the spread of tuberculosis, which resurged as a major public health threat in the 1990s.

President Obama appointed Hamburg soon after taking office in 2009. Now 59, she is one of the agency's longest-serving commissioners.

Nancy Crotti is a contributor to Qmed and MPMN.

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